CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report

HistoCore Peloris recalled by Leica Biosystems Melbourne Pty

Leica Biosystems Melbourne is recalling HistoCore Peloris 3, distributed in 14 states. The recall was initiated on 2 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 09349458004811; Serial Numbers: 45111117, 45111154, 45111155, 45111156, 45111157, 45111158, 45111159, 45111160, 45111161, 45111162, 45111164, 45111166, 45111167, 45111168, 45111169, 45111170, 45111171, 45111174, 45111175, 45111176, 45111177, 45111178, 45111179, 45111180, 45111181, 45111182, 45111183. 08/12/2025 UPDATE: Additional Serial Numbers: 45111064, 45111065, 45111067, 45111068, 45111069, 45111070, 45111071, 45111073, 45111074, 45111075, 45111076, 45111077, 45111078, 45111079, 45111080, 45111081, 45111082, 45111084, 45111086, 45111087, 45111088, 45111089, 45111090, 45111091, 45111092, 45111093, 45111094, 45111095, 45111097, 45111098, 45111099, 45111100, 45111101, 45111102, 45111103, 45111104, 45111108, 45111109, 45111110, 45111111, 45111112, 45111113, 45111114, 45111115, 45111116, 45111120, 45111122, 45111123, 45111124, 45111125, 45111126, 45111127, 45111128, 45111129, 45111130, 45111131, 45111132, 45111133, 45111134, 45111135, 45111136, 45111137, 45111139, 45111140, 45111141, 45111142, 45111143, 45111144, 45111145, 45111146, 45111147, 45111148, 45111149, 45111150, 45111151, 45111152, 45111163.

Quantity recalled77 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1683-2025
FDA event ID: 96612
Recalling firm: Leica Biosystems Melbourne, Mount Waverley
Classification: Class II
Status: Ongoing
Recall initiated: 2 Apr 2025
FDA classified: 28 Apr 2025
Reported: 7 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Medical Software

Timeline

2 Apr 2025	Recall initiated by company
28 Apr 2025	Classified by FDA	+26 days
7 May 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a leakage issue associated with the tubing in the manifold of the instrument.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

Where it was distributed

US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.

Arizona California Florida Minnesota North Carolina New Jersey New York Ohio Pennsylvania Tennessee Texas Utah Virginia Wisconsin

Questions about this recall

Why was it recalled?

There is a leakage issue associated with the tubing in the manifold of the instrument.

Which lots are affected?

UDI-DI: 09349458004811; Serial Numbers: 45111117, 45111154, 45111155, 45111156, 45111157, 45111158, 45111159, 45111160, 45111161, 45111162, 45111164, 45111166, 45111167, 45111168, 45111169, 45111170, 45111171, 45111174, 45111175, 45111176, 45111177, 45111178, 45111179, 45111180, 45111181, 45111182, 45111183. 08/12/2025 UPDATE: Additional Serial Numbers: 45111064, 45111065, 45111067, 45111068, 45111069, 45111070, 45111071, 45111073, 45111074, 45111075, 45111076, 45111077, 45111078, 45111079, 45111080, 45111081, 45111082, 45111084, 45111086, 45111087, 45111088, 45111089, 45111090, 45111091, 45111092, 45111093, 45111094, 45111095, 45111097, 45111098, 45111099, 45111100, 45111101, 45111102, 45111103, 45111104, 45111108, 45111109, 45111110, 45111111, 45111112, 45111113, 45111114, 45111115, 45111116, 45111120, 45111122, 45111123, 45111124, 45111125, 45111126, 45111127, 45111128, 45111129, 45111130, 45111131, 45111132, 45111133, 45111134, 45111135, 45111136, 45111137, 45111139, 45111140, 45111141, 45111142, 45111143, 45111144, 45111145, 45111146, 45111147, 45111148, 45111149, 45111150, 45111151, 45111152, 45111163.

Where was it sold?

US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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